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Tag: FDA

A total of 98 posts are filed under FDA
Rare Disease Report: FDA Approves Unituxin (dinutuximab) for Neuroblastoma in Children
The U.S. Food and Drug Administration (FDA) has approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with… Continue Reading
RAREcast: How the Orphan Drug Act Reshaped the Rare Disease Landscape
The U.S. Food and Drug Administration approved more than 230 new drugs to treat rare diseases in the past decade and there are currently… Continue Reading
Greater Patient Access to Fed-Funded Scientific Research? Coming in 2015
Rare disease patients, advocacy organizations, and researchers will soon have greater access to results from federally-funded scientific… Continue Reading
North Dakota Lawmakers Try to Help Family Fight Rare Disease
North Dakota lawmakers want to help a Grace city family who is struggling with a rare genetic disease. The Kulsrud brothers suffer from… Continue Reading
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FDA Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the… Continue Reading
Synageva Biopharma Makes New Moves with Sebelipase Alfa for LAL Deficiency
Synageva BioPharma Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa First-Ever Product Submission… Continue Reading
More Patients Help Drug Companies Pass Valley of Death
There’s no question the pharmaceutical industry has boatloads of cash. Global sales of prescription drugs total nearly $1 trillion… Continue Reading